Disposable ECG Electrodes
by Shanghai Heramed Tech Co., Ltd. 33 variants
Ref TF15Model TF01,TF02,TF03,TF04,TF05,TF06,TF07,TF08,TF09,TF10,TF11,TF12,TF13,TF14,TF15,TF16, TN01,TN02,TN03,TN04,TN05,TN06,TN07,TN08,TN08,TN09, etc
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697881287ECGELECTRODESQ3 06978812870149 | Date17 Jul 2025 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Disposable ECG Electrodes
- Model / Reference
- TF01, TF02, TF03, TF04, TF05, TF06, TF07, TF08, TF09, TF10, TF11, TF12, TF13, TF14, TF15, TF16, TN01, TN02, TN03, TN04, TN05, TN06, TN07, TN08, TN09, etc
- Primary DI / UDI-DI
- 06978812870149
- Basic UDI-DI
- 697881287ECGELECTRODESQ3
- EMDN Code
- C020501 ECG electrodes
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000048531
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Shanghai Heramed Tech Co., Ltd.
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No